A
Indication details
- Combined Agent(s)
- Platinum-doublet ChT
- Control Arm
- Placebo + platinum-doublet ChT
- Therapeutic Indication
- Nivolumab with platinum-doublet chemotherapy as neoadjuvant treatment, followed by single-agent nivolumab after surgery as adjuvant treatment, for adults with resectable (tumors ≥ 4 cm and/or node positive) non-small cell lung cancer (NSCLC) and no known epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) rearrangements.
- Tumour Type
-
Thoracic Malignancies
- Tumour Sub-type
- Non-small-cell Lung Cancer
- Tumour Stage
- Resectable
- Tumour Sub-Group
- EGFR-, ALK-
- Trial Name
- CheckMate-77T
- NCT Number
- NCT04025879
- Trial Phase
- Phase III
Approval details
- FDA Approval
- FDA approval October 2024
Primary Outcome(s)
- Primary Outcome(s)
- EFS. OS as secondary endpoint
- Evaluated Outcome
- EFS
- Form(s)
- Form 1
Outcome Data
- OS HR
- Immature
- EFS control
- 18 months. EFS 50%
- EFS gain
- 18 months EFS gain 20.2%
- EFS HR
- EFS HR (97.36% CI): 0.58 (0.42-0.81) P<0.001
Adjustments
- QoL Comment
-
Not qualified for an ESMO-MCBS credit
- Toxicity Comment
-
19.3 % discontinuation due to AEs
Score (after adjustments)
- Curative score
-
A
Scorecard details
- ESMO-MCBS version
- ESMO-MCBS v1.1
- Scorecard ID
- 477
- Scorecard version
- 1
- Issue date
- 04.12.204
Legend
Information about symbols, abbrevations and color codes
Red = negative
Green = positive
Grey = neutral
?
Grey + ? = neutral with pending data
- DFS
- Disease-Free Survival
- DoR
- Duration of Response
- EFS
- Event-Free Survival
- HR
- Hazard Ratio
- NEB
- No evaluable benefit
- NI
- Non-inferiority Study
- ORR
- Overall Response Rate
- OS
- Overall Surival
- pCR
- Pathological Complete Response/Remission
- PFS
- Progression-Free Survival
- QoL
- Quality of Life
- RFS
- Relapse-Free Survival
- RR
- Response Rate
QoL adjustments
Other adjustments*
Serious and disabling adverse effects
Red = negative / deterioration
Green = positive / improvement
QoL adjustments
Red = negative / deterioration
Green = positive / improvement
Other adjustments*
Red = negative / deterioration
Green = positive / improvement
Serious and disabling adverse effects
Red = negative / deterioration
Green = positive / improvement
* Other adjustments include:
- Long-term plateau in the survival curve
- Long-term plateau in the PFS curve
- Early stopping or crossover
- Only improved PFS mature data shows no OS advantage and no improved Qol.